Acute Myeloid Leukemia Therapy Granted Fast Track Status

Celator Pharmaceuticals announced that the Food and Drug Administration (FDA) has granted Fast Track status to CPX-351 (cytarabine:daunorubicin) for the treatment of elderly patients with secondary acute myeloid leukemia (AML). CPX-351 is a liposomal formulation of a synergistic 5:1 molar ratio of cytarabine and daunorubicin.

CPX-351 is currently being evaluated in a multicenter Phase 3 study vs. “7+3” in 300 patients 60–75 years old with untreated high risk (secondary) AML. Results for the primary endpoint of overall survival is expected in the first quarter of 2016.

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Previously CPX-351 was granted Orphan Drug status by the FDA for the treatment of AML.

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